Culturally Tailored Diabetes Education on Self-Management of Adult Hispanic Males With Type 2 Diabetes Mellitus

NCT06897618 | Terminated

• 1 other identifier: Pro2025-0124
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetes mellitus (DM) is a global public health concern. In the United States, adult Hispanic males are particularly vulnerable to type 2 diabetes mellitus and are more likely to develop complications and subsequently die from it, compared to non-Hispanic White males. Evidence suggests good self-management behaviors can potentially prevent disease-related complications and improve clinical outcomes. The American Diabetes Association and Association of Diabetes Care and Education Specialists have endorsed diabetes self-management education as a necessary component of care for all individuals living with the disease. However, adult Hispanic males with type 2 diabetes mellitus living in the Middle Atlantic Region of the U.S., especially those who are underserved, typically lack access to formal diabetes self-management education (DSME). Further, the majority have never participated in such educational activities. A large body of evidence suggests DSME can effectively improve self-management behaviors in diverse populations around the globe. The purpose of the proposed study is to examine the effect of culturally tailored diabetes education on self-management behaviors of adult Hispanic males, aged 18-64 years, with type 2 diabetes mellitus living in the Middle Atlantic Region of the U.S. This study can shed more light on the effectiveness of community-based, culturally tailored diabetes educational activities in this vulnerable population and guide future efforts towards enhancing self-management.

Conditions

Diabetes Mellitus; Diabete Type 2

Keywords

Type 2 diabetes; Self-Management Behaviors; Culturally Tailored Diabetes Education

Outcome Measures

Primary Outcomes (3)

• Healthy Eating

  Healthy eating behaviors will be measured by self-reported data on diet adherence utilizing scoring derived from the Spanish version of the Summary of Diabetes Self-Care Assessment (SDSCA) scale. Items 1-5 relate to dietary behaviors, for example, "how many of the last seven days have you followed a healthful eating plan?" Diet will be scored using the mean number of days for items 1-5, using a reverse score for item 4. Scores range from 0 to 7 with higher numbers corresponding to higher levels of self-care activity performance

  At baseline and right after the 5 week educational intervention

• Staying Active

  Physical activity behaviors will be measured by self-reported data on exercise adherence utilizing scoring derived from the Spanish version of the Summary of Diabetes Self-Care Assessment (SDSCA) scale. Items 6-7 pertain to exercise activity, for example, "on how many of the last seven days did you participate in at least 30 minutes of physical activity?" Exercise will be scored using the mean number of days for items 6 and 7. Scores range from 0 to 7 with higher numbers corresponding to higher levels of self-care activity performance

  At baseline and right after the 5 week educational intervention

• Medication Use

  Medication use behaviors will be measured by self-reported data on medication adherence utilizing scoring derived from the Spanish version of the Summary of Diabetes Self-Care Assessment (SDSCA) scale. Medication use will be scored using total number of days for item 12. Scores range from 0 to 7 with higher numbers corresponding to higher levels of self-care activity performance

  At baseline and right after the 5 week educational intervention

Study Arms (1)

Culturally Tailored Diabetes Education

EXPERIMENTAL

Five weeks of culturally tailored diabetes self-management education modeled after Association of Diabetes Care and Education Seven-item Framework (ADCES7).

Behavioral: Culturally tailored diabetes self-management education

Interventions

Culturally tailored diabetes self-management education BEHAVIORAL

Five weeks of culturally tailored diabetes self-management education modeled after Association of Diabetes Care and Education Seven-item Framework (ADCES7).

Culturally Tailored Diabetes Education

Eligibility Criteria

• Age: 18 Years - 64 Years
• Gender Eligibility Details: Adult Hispanic males 18-64 at time of study intervention
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: Adult Hispanic males 18-64 at time of study intervention.
• Diagnosis Codes: Patients with self-reported diagnosis of T2DM without complex, co-morbid conditions such as severe kidney disease and terminal illnesses such as cancer.
• English or Spanish speaking

You may not qualify if:

• Outside the age range listed above
• Without a diagnosis of type 2 diabetes

Sponsors & Collaborators

• Hackensack Meridian Health: lead

Study Sites (1)

Hackensack Meridian Health, JFK University Medical

Plainfield, New Jersey, 07060, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Beryl O'Donnell, MSN, RN, NP-C

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 27, 2025
• Study Start: September 12, 2025
• Primary Completion: December 19, 2025
• Study Completion: December 19, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)